Regulatory Affairs Manager (f/m/d)

PAUL HARTMANN AG

Berufsfeld
Gesundheit und medizinische Versorgung

Jetzt bewerben

Regulatory Affairs Manager (f/m/d), PAUL HARTMANN AG

At HARTMANN, we're all in to help , care , protect and grow . We support healthcare professionals, that they can focus on what really matters: to positively impact people's life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make.

Join our team as

DEU-Heidenheim

At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d), we offer you a varied and challenging position in an international environment. Here, you can develop your skills and play an active role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.

Responsibilities:

Provide and update documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance
Cross-functional communication with other departments such as Marketing and R&D to ensure required input documentation is up to date
Coordinate external service providers to support clinical evaluation documentation, PMCF and PMS
Determine clinical evidence requirements according to MDR and relevant MDCGs
Identify equivalence to existing devices, if required, in accordance with MDRs and relevant MDCGs.
Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
Provide searches in relevant vigilance databases
Support for risk analysis and study planning for CE and PMCF studies

Qualification:

University degree in life science/natural science or an equivalent qualification
Professional experience in the medical device environment or another regulatory field of work
Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs
Experience in literature search and review required as well as knowledge of regulatory medical writing
Knowledge of database management
Open and competent attitude when working with your stakeholders
IT affinity and proficiency with the MS Office package
Fluent written and spoken English

Benefits:

Flexible working conditions, such as flexible working hours and mobile working
International Mobile Working
Attractive ways of combining work and family life, e.g. childcare subsidy
30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
Company pension plan with attractive employer contribution incl. matching model for deferred compensation
Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
Job Bike Leasing
Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform

Shape a career that's focused on healthcare customers, fit for the future and grounded in a culture of trust and openness. Apply now via our online platform.

Your personal contact:

Isabel Proske

Jetzt bewerben